Safe, efficient, and effective treatment for both paroxysmal and persistent atrial fibrillationDUBLIN, Dec. 13, 2023 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF).

阵发性和持续性房颤的安全、高效和有效治疗都柏林，2023年12月13日/PRNewswire/--美敦力公司（纽约证券交易所：MDT），全球医疗技术领导者，今天宣布，美国食品和药物管理局（FDA）已批准PulseSelect脉冲场消融（PFA）系统用于治疗阵发性和持续性心房颤动（AF）。

This is the first PFA technology to receive FDA approval and follows the recent European CE (Conformité Européenne) Mark of the PulseSelect PFA system in November..

这是第一项获得FDA批准的PFA技术，并遵循了11月PulseSelect PFA系统最近的欧洲CE（ConformitéEuropeéenne）标志。。

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PulseSelect

脉冲选择

PulseSelect PFA System

脉冲选择PFA系统

'Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency1.  It's a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients,' said Rebecca Seidel, SVP and President of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio.

“推出首个FDA批准的PFA技术不仅仅是一个里程碑；PulseSelect PFA系统正在为AF消融的安全性制定新的标准，具有出色的疗效和效率1。心脏消融解决方案业务总裁兼高级副总裁丽贝卡·塞德尔（RebeccaSeidel）说，这是实现我们为患者提供破坏性电生理解决方案的愿景的重要一步，该业务是心血管产品组合的一部分。

'The PulseSelect PFA system, together with the CE Marked Affera™ mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence.'.

“PulseSelect PFA系统，以及CE标记的Affera™测绘和消融系统以及我们强大的冷冻平台，使我们能够为临床医生及其患者提供广泛的解决方案组合，这些解决方案都是通过多年的研究开发出来的，并得到了令人信服的科学证据的支持。”。

The PulseSelect PFA system was engineered with differentiated safety features and provides rapid, effective pulmonary vein isolation (PVI) through consistent and predictable energy delivery and catheter maneuverability. The system is designed to enable a seamless transition to PFA in a clinician's preferred workflow2.

PulseSelect PFA系统具有不同的安全功能，并通过一致且可预测的能量输送和导管可操作性提供快速有效的肺静脉隔离（PVI）。该系统旨在实现临床医生首选工作流程中向PFA的无缝过渡2。

The PulseSelect PFA system's safety, efficacy, and efficiency is supported by the PULSED AF study, which showed a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AF patients1..

脉冲AF研究支持PulseSelect PFA系统的安全性，有效性和效率，该研究显示阵发性和持续性AF患者的安全事件发生率为0.7%，临床成功率为80%1。。

'The PulseSelect PFA system ushers the EP community to a new era of safe, effective, and efficient AF ablation that overcomes many challenges in our current practice,' said Dr. Amin Al-Ahmad, clinical cardiac electrophysiologist at St. David's Medical Center in Austin, TX and one of 67 global operators in the PULSED AF trial.

德克萨斯州奥斯汀圣大卫医学中心临床心脏电生理学家阿明·艾哈迈德博士（AminAl-Ahmad）说，PulseSelect PFA系统将EP社区带入一个安全、有效和高效的房颤消融新时代，克服了我们目前实践中的许多挑战，他是脉冲房颤试验的67名全球操作者之一。

'In my clinical experience with the catheter, it was designed for AF ablation procedures. The learning curve in using the catheter and system is short, and the catheter enables the operator to deliver fast and controlled pulsed field energy for AF ablation.'The PulseSelect PFA system also includes the following:.

“根据我对导管的临床经验，它是为房颤消融手术设计的。使用导管和系统的学习曲线很短，导管使操作者能够为房颤消融提供快速和可控的脉冲场能量。”PulseSelect PFA系统还包括以下内容：。

Designed as a plug-and-play system, PulseSelect can be used with any mapping system or with just fluoroscopy2.

PulseSelect设计为即插即用系统，可用于任何绘图系统或仅用于荧光透视2。

Built-in safety features such as a phrenic nerve test pulse, a non-therapeutic low voltage pulse that provides a preemptive assessment of catheter proximity to the phrenic nerve prior to delivering a therapeutic application.

内置的安全功能，例如膈神经测试脉冲，一种非治疗性低压脉冲，可在提供治疗应用之前对导管与膈神经的接近程度进行先发制人的评估。

Fixed spacing for the nine-electrode catheter, which produces a predictable and consistent electric field for contiguous ablation2. In addition to ablation, the nine electrodes can also be used for pacing and sensing.

九电极导管的固定间距，为连续消融产生可预测且一致的电场2。除消融外，九个电极还可用于起搏和传感。

The small, 9Fr bidirectional catheter enhances maneuverability and access to various anatomical structures and is compatible with a 10Fr sheath, including the custom bidirectional FlexCath Contour™ sheath.

小的9Fr双向导管增强了可操作性和对各种解剖结构的访问，并且与10Fr护套兼容，包括定制的双向FlexCath轮廓™护套。

'We are thrilled to see the continuous innovation of our legacy Cryoablation portfolio alongside the approval of the PulseSelect PFA system in the U.S.,' said Khaldoun Tarakji, MD MPH, Chief Medical Officer of the Cardiac Ablation Solutions business at Medtronic. 'Every patient deserves the best care.

美敦力（Medtronic）心脏消融解决方案业务首席医疗官、公共卫生硕士KhaldounTarakji说：“我们很高兴看到传统冷冻消融组合的不断创新以及美国PulseSelect PFA系统的批准。”每个病人都应该得到最好的照顾。

What motivates all of us at Medtronic is the privilege of serving patients by empowering electrophysiologists globally with the safest and most effective ablation technologies that seamlessly integrate with their workflows and enable them to tailor therapy based on their patients' needs.'The PulseSelect PFA system is also the first FDA Breakthrough-designated PFA technology to be approved.

美敦力激励我们所有人的是，通过向全球电生理学家提供最安全和最有效的消融技术，为患者提供服务的特权，这些技术与他们的工作流程无缝集成，使他们能够根据患者的需求定制治疗PulseSelect PFA系统也是FDA首次批准的突破性PFA技术。

The designation is intended to help patients gain more timely access to medical devices that have the potential to make a significant impact in the diagnosis or treatment of life-threatening conditions.Commercialization of the PulseSelect PFA system will start in early 2024.About Atrial Fibrillation and Pulsed Field AblationAF is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide3. AF is a progressive disease, meaning it can become worse over time and can increase the risk of serious complications including heart failure, stroke and increased risk of death.4-7 Current ablation technologies rely on thermal effects to target cardiac tissue and risk damage to additional collateral structures in the heart.

该名称旨在帮助患者更及时地获得可能对威胁生命的疾病的诊断或治疗产生重大影响的医疗设备。PulseSelect PFA系统的商业化将于2024年初开始。关于心房颤动和脉冲场消融AF是最常见且治疗不足的心律失常之一，影响全球6000多万人3。AF是一种进行性疾病，意味着它可能会随着时间的推移而恶化，并可能增加包括心力衰竭在内的严重并发症的风险，中风和死亡风险增加[4-7]。目前的消融技术依赖于热效应来靶向心脏组织，并有损害心脏其他侧支结构的风险。

PFA is a breakthrough ablation technology that uses pulsed electric fields to efficiently isolate the pulmonary veins for the treatment of AF. Because the mechanism of cell death is non-thermal, the risk of collateral structure damage is potentially lower.  About MedtronicBold thinking. Bolder actions.

PFA是一种突破性的消融技术，它使用脉冲电场有效隔离肺静脉以治疗房颤。由于细胞死亡的机制是非热的，因此侧支结构损伤的风险可能较低。关于美敦力思维。更大胆的行动。

We are Medtronic. Medtronic.

我们是美敦力。美敦力。

Verma A, et al. Circulation. 2023;147:1422-1432

Verma A等人，《循环》，2023年；147:1422-1432年

Medtronic data on file. November 2023.

美敦力数据存档。2023年11月。

Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.

Roth GA，Mensah GA，Johnson CO等人。1990-2019年全球心血管疾病负担和危险因素：GBD 2019研究的更新。J Am Coll Cardiol 2020；76:2982-3021。

Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.

Miyasaka Y，Barnes ME，Bailey KR等。首次房颤患者的死亡率趋势：一项为期21年的社区研究。J Am Coll Cardiol 2007；49:986-92年。

Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.

Hindricks G，Potpara T，Dagres N等人2020年与欧洲心胸外科协会（EACTS）合作制定的ESC房颤诊断和管理指南。欧洲心脏病杂志2020。

Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.

沃尔夫宾夕法尼亚州，雅培路，坎内尔WB。心房颤动是中风的独立危险因素：弗雷明汉研究。中风1991；22:983-8年。

Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Lubitz SA，Moser C，Sullivan L等人。社区心房颤动模式和随后中风，心力衰竭或死亡的风险。J Am心脏协会2013；2： e000126

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